Stakeholders – Marketing Authorisation Holders (MAH)

High level project plan

M3 – M6 / 2018
Belgian NMVS connected to Hub in IQE
                Possibility for MAHs to test data loads and transactions in IQE
M7 / 2018
           Belgian NMVS version 1.1 connected to Hub in PROD environment
           Possibility for MAHs to load data in the Live environment

high level project plan

The BMVS (Belgian Verification System) is now connected in IQE environment to the EU HUB.
OBPs who desire to load data in IQE environment can do so after first contacting BeMVO at MAH@bemvo.be
The loading specifications for product and pack data for Belgium and Luxembourg can be consulted in following document:  BMVSLoadingSpecs.pdf

Important:

MAH’s must communicate as soon as possible the GTin and corresponding CNK to gtin@abp.be to be included in the conversion table. GTins missing in the conversion table might be rejected by end users when performing verifications.
The quality of the print of the 2D-Matrix on the packs is critical to ensure a smooth delivery of the medicines in the supply chain. 
The MAH can ask GS1 to verify the quality of the print(s).

MAH’s  take an important responsibility in the deployment of the Falsified Medicines Directive.

They need to:

  • Make sure the packaging is compliant with the requirements on the safety features
  • Bring the new packages to market in a transition period
  • Keep record of applied safety features 
  • Engage with all stakeholders in the distribution chain
  • Set up an organization to implement the system
  • Organise support for the different stakeholders
  • Finance the central and national databases
  • Ensure high quality levels and state of the art security procedures
  • Align with National Competent authorities on country specific requirements
  • Adapt the production line and keep record of the generated Unique Identifiers
  • Connect to the EU Hub and have a smooth process for loading the data (product and codes)
  • Register to the National Verification system to allow verification by end-users in the respective countries.

 Extended information and ToDo’s lists can be found in following documents:

MAH_Bemvo_web-en

MAH_Bemvo_web2-en

It is critical for the MAH to have the Product information and Unique Identifiers loaded to the National systems. Non-compliance will result in Pharmacies and Hospitals not being able to deliver the products to the patients.

Two important steps to start now are:

  1. Register and connect to EU Hub

Extended information on the procedure can be found on the EMVO site:
Onboarding : https://emvo-medicines.eu/pharmaceutical-companies/

  1. Register to the Belgian Verification System

Delivery of products for MAH’s that have not registered to the national system will not be possible after February 9, 2019. More information on the process can be found in the Registration section